Cleared Special

K152861 - Aquasil Ultra + Smart Wetting Impression Material

K152861 is an FDA 510(k) clearance for Aquasil Ultra + Smart Wetting Impressio..., manufactured by Dentply International, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Special 510(k) pathway after a 156-day FDA review.

K152861 · Dentply International, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
156d
Days
Class 2
Risk

K152861 is an FDA 510(k) clearance for the Aquasil Ultra + Smart Wetting Impression Material. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentply International, Inc. (York, US). The FDA issued a Cleared decision on March 4, 2016 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K152861

510(k) Number K152861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date March 04, 2016
Days to Decision 156 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 128d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 359
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